Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)
1 other identifier
interventional
90
1 country
1
Brief Summary
To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate. To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 26, 2017
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJanuary 9, 2020
January 1, 2020
7 years
October 26, 2017
January 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Skeletal relapse
Relapse in milimeters
2 years
Secondary Outcomes (1)
Dental relapse
2 years
Study Arms (5)
Bone Borne distractor
ACTIVE COMPARATORThe device being investigated, Boneborne distraction appliance
Tooth borne distractor
OTHERThe control device Toothborne distraction appliance
Segmental LF1 osteotomy group 1
NO INTERVENTIONControl Group, no stabilization of palatal vault
Segmental LF1 osteotomy group 2
ACTIVE COMPARATORTestgroup, biodegradable plate at osteotomy site in palate
Segmental LF1 osteotomy group 3
ACTIVE COMPARATORTestgroup, autologous bonegraft at palatal osteotomy site
Interventions
Eligibility Criteria
You may qualify if:
- Mature non-syndromic patients scheduled for transverse expansion of the maxilla
You may not qualify if:
- Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg University Hospital
Aalborg, 9000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tue Blæhr
Aalborg University Hospital
Central Study Contacts
Thomas Starch-jensen, DDS
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Oral and Maxillofacial Surgery
Study Record Dates
First Submitted
October 26, 2017
First Posted
April 30, 2018
Study Start
August 1, 2016
Primary Completion
August 1, 2023
Study Completion
August 1, 2025
Last Updated
January 9, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share